Phase III study of Positron/Computerized Tomography (PETCT) with F-18-PSMA-1007 versus F-18-Fluorocholine to compare the detection rate of prostate cancer lesions in patients with biochemical recurrence after previous definite treatment for the primary localized tumor

BIOKOSMOS S.A.0 个研究点目标入组 190 人开始时间: 2019年7月25日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Male with original diagnosis of prostate carcinoma with prior definitive therapy
•2. Suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above
•nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after
•prostatectomy)
•3. Life expectancy of 6 months or more as judged by the investigator
•4. Willing and able to undergo all study procedures
•5. Informed consent in writing (dated and signed)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 114
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 76

•1. Age: less than18 years
•2. Contraindications for F-18-Fluorocholine
•3. Contraindications for any of the ingredients of F-18-PSMA-1007
•4. Close affiliation with the investigational site; e.g. first-degree relative of the investigator
•5. Participating in another therapeutic clinical trial or has completed study participation in
•another therapeutic clinical trial within 5 days of enrolment into this trial
•6. Having been previously enrolled in this clinical trial
•7. Mental conditions rendering the subject incapable to understand the nature, scope, and
•consequences of the trial
•8. Being clinically unstable or requiring emergency treatment

发起方

BIOKOSMOS S.A.